NEW YORK (GenomeWeb News) – ArrayIt today said that it has signed an agreement with Docro to assist in its efforts to win US Food and Drug Administration clearance for its OvaDx test.
ArrayIt's OvaDx is a pre-symptomatic ovarian cancer test that includes 100 proteomic biomarkers in a microarray format. The Sunnyvale, Calif.-based firm said that the test can detect both early- and late-stage ovarian cancer.
Docro, which is based in Seymour, Conn., helps firms with clinical trials of in vitro diagnostics and has assisted firms in gaining 39 pre-market approvals and 46 510(k) applications, according to ArrayIt. It also noted that Docro has a 99 percent success rate with the FDA.
"Docro brings a breadth and depth of experience that matches the importance of bringing the first early stage pre-symptomatic ovarian cancer screening test to market," Arrayit CEO Rene Schena.